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For a bit of background, ECHELON-1 is a randomized, multicenter trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in 1,334 patients with previously untreated advanced classical Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

Getting into the results, the ECHELON-1 trial demonstrated that combination treatment with ADCETRIS resulted in a statistically significant improvement in modified PFS versus the control arm as assessed by an Independent Review Facility (hazard ratio=0.770; p-value=0.035). The two-year modified PFS rate for patients in the ADCETRIS arm was 82.1% compared to 77.2% in the control arm. Interim analysis of overall survival (OS), the key secondary endpoint, also trended in favor of the ADCETRIS+AVD arm.

The safety profile of ADCETRIS+AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen. There was an increased incidence of febrile neutropenia and peripheral neuropathy in the ADCETRIS+AVD arm. Febrile neutropenia (fever in patients with abnormally low neutrophil granulocytes in the blood) was reduced through the use of prophylactic growth factors in a subset of patients, and peripheral neuropathy was managed through dose modifications. The control arm had an increased rate and severity of pulmonary toxicity.

SGEN and Takeda (TKPYY) are jointly developing ADCETRIS. Under the terms of the collaboration agreement, SGEN has U.S. and Canadian commercialization rights and TKPYY has rights to commercialize ADCETRIS in the rest of the world. SGEN and TKPYY are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where TKPYY is solely responsible for development costs.

An abstract will be submitted for data presentation at the American Society of Hematology (ASH) annual meeting, December 9-12, 2017, in Atlanta, Ga.